D-1546-2014 Class I Terminated
FDA drug recall D-1546-2014 was initiated by Pharmacy Creations on June 25, 2014 and is designated Class I. Reason for recall: Non-Sterility: Pharmacy Creations is recalling Ascorbic Acid 500 mg/mL 50 mL vials due to mold contamination. The recall status is terminated (terminated September 19, 2016). Affected quantity: 70 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- August 27, 2014
- Initiation Date
- June 25, 2014
- Termination Date
- September 19, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 70 vials
Product Description
Ascorbic Acid 500 mg/mL Sterile Injection, 50 mL Multi-dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869.
Reason for Recall
Non-Sterility: Pharmacy Creations is recalling Ascorbic Acid 500 mg/mL 50 mL vials due to mold contamination.
Distribution Pattern
NY, NJ, and Puerto Rico
Code Information
Lot: 06062014@8, Do Not Use Beyond 12/03/2014